FDA Approves Illuccix for Prostate Cancer Imaging

On December 20, 2021, the U.S. Food and Drug Administration (FDA) approved Illuccix^®, a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, which is a radioactive diagnostic agent indicated for positron emission tomography of prostate-specific membrane antigen positive lesions in patients with prostate cancer with:

• suspected metastasis who are candidates for initial definitive therapy
• suspected recurrence based on elevated serum prostate-specific antigen level.